1. Field of the Invention
The present invention is directed to an intravenous container in combination with separate containers for medicinal agents, such as antibiotics to be reconstituted with the intravenous fluid, and to novel means for jointly storing the two containers and intermixing their contents before administration to a patient.
2. Brief Description of the Prior Art
Containers for intravenous fluids, such as saline or glucose solutions, are well known in the prior art. Moreover, various devices for administering the intravenous fluids with or without medication, nutrients, vitamins, and the like, are also well known in the art.
With regard to some medicinal agents, the prior art has, however, experienced particular difficulty, in that these medicinal agents lose their therapeutic effectiveness, and may even become toxic, when they are dissolved in or admixed with the intravenous fluid for a prolonged period of time. Specifically, but not exclusively, certain antibiotics are stable for prolonged periods of time only in the solid state; once dissolved in an intravenous fluid they must be refrigerated or promptly administered to a patient. In this connection, the common practice in the art of dissolving an antibiotic (or other medicinal agent, such as a chemotherapy drug) in the intravenous fluid, just before administration to a patient, is usually termed "reconstituting" the antibiotic.
In accordance with what is perhaps the most traditional method of "reconstituting", a relatively small volume of intravenous fluid is withdrawn from a container for the fluid with a hypodermic needle and syringe, and the withdrawn fluid is injected through a resilient membrane seal into a small container or vial for the solid antibiotic. Then the solid antibiotic is dissolved in the injected fluid. Thereafter, the antibiotic solution is again withdrawn from the vial with a hypodermic syringe and needle.
Sometimes the antibiotic solution, having been obtained in the above-described manner, is directly injected into a patient. Many times, however, for medical reasons it is desired to dilute the antibiotic (or other medicinal agent or nutrient) solution with more intravenous fluid, and to slowly intravenously infuse the diluted solution to the patient through an intravenous administration (i.v.) set. For this purpose, the freshly obtained, relatively concentrated antibiotic (or other medicinal agent or nutrient) solution is usually injected through another self-sealing resilient membrane seal to a manufacturer's "minibag" or like intravenous bottle or bag containing a larger volume (approximately 50 to 100 ml) of the intravenous fluid. After mixing, the resulting more dilute antibiotic (or other medicinal agent or nutrient) solution is slowly infused into the patient through one or more i.v. sets which are hooked up to the manufacturer's "minibag" or like bottle or bag.
Those skilled in the art know well that the foregoing steps and manipulations must be performed without jeopardizing the sterility of the substances infused to the patient. Those skilled in the art also recognize that the more steps are involved in manipulating the substances, the greater is the chance for contamination, and for harmful or even fatal consequences to the patient.
Because the dissolution of solid or lypholized antibiotics (and of other substances) and subsequent dilution and administration to patients is performed routinely and in large numbers in virtually all hospitals in the United States of America and in other industrialized countries, the procedure involved must not only be safe, but also needs to be fast and relatively inexpensive.
The prior art has developed several devices and methods in an attempt to satisfy the foregoing requirements.
More particularly, one prior art device, designed to simplify the above-summarized manual procedure of drug dissolution and subsequent dilution, is sold by IVAC Corporation under the CRIS (Controlled Release Infusion System) mark. This device comprises a valve fitting controlled by a rotatable dial. The valve fitting includes a hollow spike surrounded by suitable plastic grips to engage the neck of a substantially standard small (5 to 15 ml) container for the solid antibiotic. The valve fitting includes two connections fluidly connecting the valve respectively to a manufacturer's "minibag", bottle, or large volume bottle, or plastic bag, and to an intravenous set. Before the valve fitting is used, the drug in the small container is dissolved by injection of a small amount (commonly 5 to 20 ml) intravenous fluid. Thereafter, the small bottle is connected to the valve fitting in a position where the hollow spike establishes fluid communication with the valve, and the plastic grips hold the small container in place. The manufacturer's "minibag", bottle, large volume bottle, or plastic bag is connected to the valve fitting as the source of the intravenous fluid which is used to dilute the drug solution. The interior design of the valve fitting is such that the inflow of the drug solution to the stream of intravenous fluid flowing through the valve may be closed-off entirely. Alternatively, the drug solution from the small vial is slowly "leaked" through the valve fitting, so that the drug solution attains large dilution by the intravenous fluid. Disadvantages of this (CRIS) system include the need for separately dissolving the drug in the small container before the small container is affixed to the valve fitting, and the high cost of the valve fitting itself. Each valve fitting, of course, should be attached only once to a large volume bottle, or plastic bag, and for safety reasons should be discarded after such use.
Still another prior art system, made by American McGaw, utilizes a plastic adapter which has a hollow spike and a tube in fluid communication with the spike. The spike is surrounded by plastic grips designed to grab and hold small standard containers or vials for drugs, such as the above-mentioned 5 to 15 ml standard size vials for solid reconstitutable antibiotics. The tube is designed to penetrate the plug of a manufacturer's specially designed "minibag". In accordance with this system, the small container is connected with the "minibag", and the drug is dissolved by adding part of the intravenous solution contained in the bag. Thereafter, the drug solution is transferred back from the vial through the tube to the bag for subsequent infusion to the patient. Disadvantages of the just-described system include the system's relatively high cost and that the process of inserting the tube into the "minibag" is somewhat awkward and requires substantial manual dexterity.
A third system relatively widely used in the prior art is distributed by Abbott Laboratories. This system requires a "custom" small container or vial and a "custom" bag, in the sense that the vial and the bag must have matching screw thread connections. Fluid communication is established between the small vial for the antibiotic (or other drug) and the bag containing the intravenous fluid when the vial is threaded into the matching receptacle of the bag. Besides its cost, the disadvantage of this system is that the system cannot be used unless the required drug is available in the requisite custom vial.
In light of the foregoing, there is still need in the art for an improved system or apparatus which permits reconstitution of antibiotics (or other drugs) with an intravenous fluid and subsequent administration of a diluted antibiotic solution to a patient with a minimum of manipulative steps and with minimal possibility for contamination. The present invention provides such a system or apparatus.
In addition to the above-summarized practical examples of prior art, the following patents disclose subject matter which comprises relevant background or is otherwise "of interest" to the present invention: U.S. Pat. Nos. 3,544,256; 3,163,337; 4,432,750; 2,022,109; 2,138,992; 2,693,189; 3,776,229; 3,993,066; 3,976,068; 4,181,246; 4,334,535; and 4,265,760.